Invited discussant Gustavo Werutsky, MD, emphasized that health-related quality of life was consistently maintained in all phase III trials with fam-trastuzumab deruxtecan-nxki (T-DXd) in the metastatic breast cancer setting. Dr. Werutsky also highlighted the need for real-world data to understand the performance of T-DXd in elderly patients, in those with comorbidities, and to describe theprevalence of interstitial lung disease in real-world settings. “It would also be great to have a digital health app to support patients and to help us manage adverse events,” he added.

Gustavo Werutsky, MD

Finally, Dr. Werutsky called for the development of biomarkers for interstitial lung disease to predict and monitor patients more effectively. Dr. Werutsky is Chairman of the Latin American Cooperative Oncology Group and a medical oncologist in the Breast Cancer Program, Hospital Moinhos de Vento, Brazil.

Capturing the Patient Experience

Invited discussant Lisa A. Carey, MD, ScM, FASCO, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research in the Department of Medicine at the University of North Carolina, underscored the value of patient-reported outcomes in clinical trials, particularly in metastatic breast cancer trials. However, Dr. Carey also emphasized that patient-reported outcomes do not replace clinician assessment of toxicity. Rather, she noted, both serve different purposes in capturing patients’ experiences.

Lisa A. Carey, MD, ScM, FASCO

“It’s been documented that clinician-reported assessments track much more with subsequent hospitalizations and death,” Dr. Carey explained. “Patient-reported assessments, on the other hand, are much more associated with daily health status and quality of life. It is also true that patients are less likely to complete them than clinicians are, and there are significant variations between patient-reported outcomes and clinician assessment in adverse events, even when they think they’re measuring the same thing,” she added.

Dr. Carey also noted the potential issues with baseline imbalances and missing data in patient-reported outcomes, using nausea as an example in the elacestrant study. 

DISCLOSURE: Dr. Werutsky reported financial relationships with AstraZeneca, MSD, Novartis, Organon, Pfizer, and Roche. Dr. Carey reported financial relationships with Eli Lilly, Pfizer, Novartis, and Puma Biotechnology.